Stapler for mucosectomy

ABSTRACT

The head of a stapler for mucosectomy comprises an external goblet-shaped body ( 1 ) wherein an internal goblet-shaped body ( 2 ) is concentrically and slidingly located, at the edge of which a circular blade ( 3 ) is fixed. The internal goblet-shaped body ( 2 ) is provided with a central hole ( 5 ) wherein a rod ( 6 ) is slidingly inserted, at the end ( 7 ) of which an anvil ( 8; 8 ′) is fixed. One or more annular grooves ( 11 ), which are parallel and suitably spaced one from the other, are formed on the lateral surface of the rod ( 6 ) perpendicularly to the axis thereof. Said grooves ( 11 ) are intended to receive a portion of mucosa ( 9   a ) which is included in a purse string suture as the mucosa is tied around the rod ( 6 ). By retracting the rod ( 6 ) in the central hole ( 5 ) of the stem ( 2   a ) of the internal goblet-shaped body ( 2 ) the mucosa to be removed is carried into the internal goblet-shaped body ( 2 ). The anvil ( 8; 8 ′) and the circular blade ( 3 ) are moved closer one to the other, by suitable means, in order to cut the tissues when the stapler is in a closed position.

This application is a continuation of U.S. patent application Ser. No.13/594,071, filed on Aug. 24, 2012, which is a continuation of U.S.patent application Ser. No. 12/529,909, filed on Feb. 22, 2010, now U.S.Pat. No. 8,272,555, which is a National Stage Entry under 35 U.S.C.§371(a) of International Patent Application No. PCT/IT2007/000166, filedon Mar. 7, 2007. The entire content of each of the applicationsidentified above is incorporated by reference herein.

The present invention relates to a stapler for mucosectomy in holloworgans and, more particularly, a type of stapler which is provided witha central grooved rod allowing to carry out a precise mucosectomy of alarger volume of mucosal tissue.

Mucosectomy is an operation which is particularly suited for thetreatment of haemorrhoids, rectocele and rectal mucosal prolapse.Circular mechanical staplers are already known, both for applyingstaples and for applying compression devices such as e.g. fragmentablerings. Said staplers are provided with a central shaft. The objective ofmucosectomy is to remove a portion of mucosa which is as large aspossible, so as to ensure a remarkable “lifting” of the mucosa of thehollow organ.

In order to achieve this objective, in U.S. Pat. No. 6,102,271 acircular stapler is disclosed whose head comprises two concentricgoblet-shaped bodies. Two through openings are provided on the lateralsurface of said goblet-shaped bodies, in the proximity of the stemsthereof. The through openings allow the purse-string suture thread topass outwards therethrough. The suture thread can thus be pulled towardsthe outside of the above mentioned goblet-shaped bodies so as to draginto the inside thereof a volume of mucosa which is as large aspossible. The mucosa is then cut by a circular blade which is fixed tothe edge of the internal goblet-shaped body. At the same time, a shaftwhich is centrally arranged relative to the goblet-shaped bodies movesan anvil which is fixed to the end of the shaft in the proximity of theedge of the external goblet-shaped body for applying suture staples.However, the stapler described in the above mentioned patent has thedrawback that the manual pulling of the suture threads during the stepof closing the stapler does not allow to remove the mucosa in ahomogeneous and controlled way with exactness.

Object of the present invention is thus to provide a stapler formucosectomy which is free from such drawbacks. Said object is achievedby a stapler whose main characteristics are specified in the firstclaim, while other characteristics are specified in the subsequentclaims.

In order to achieve said object, the stapler according to the presentinvention is provided with a central rod having one or more annulargrooves formed on its lateral surface crosswise to its axis. Suchgrooves are intended to receive a portion of tissue when a purse-stringsuture is tied around the rod, as well as to prevent said portion oftissue from undesirably sliding along the central rod as the latter isretracted inside the stem of the internal goblet-shaped body. In orderto ensure that during said retraction of the rod the hollow body wall isdragged in a controlled and homogeneous way into the internalgoblet-shaped body, said grooves are suitably dimensioned and exactlyspaced one from the other.

Another advantage provided by the stapler according to the presentinvention is to allow a precise removal of different amounts of mucosasimply by selecting a certain annular groove among those formed andcalibrated on the rod of the stapler.

Further advantages and characteristics of the stapler according to thepresent invention will be evident to those skilled in the art from thefollowing detailed and non-limiting disclosure of two embodimentsthereof with reference to the annexed drawings wherein:

FIG. 1 is a partially sectioned side view of the head of a firstembodiment of the stapler according to the present invention in an openposition;

FIG. 2 is a longitudinally sectioned view of the head of the stapler inFIG. 1 being introduced inside a partially sectioned hollow organthrough a hollow cylindrical introducer;

FIG. 3 is a longitudinally sectioned view of the head of the stapler ina closed position inside a hollow organ through a hollow cylindricalintroducer;

FIG. 4 is a partially sectioned side view of the head of a secondembodiment of the stapler according to the present invention in an openposition;

FIG. 5 is an axonometric view of the head of the stapler of FIG. 4 in aclosed position being introduced inside a partially sectioned holloworgan through a hollow cylindrical introducer, and

FIG. 6 is a longitudinally sectioned view of the head of the stapler ofFIG. 5.

FIGS. 1 and 2 show a head of a stapler comprising in a known way anexternal goblet-shaped body 1, being provided with a first hollow stem 1a, wherein a smaller internal goblet-shaped body 2 is concentrically andslidingly provided. A circular blade 3 is fixed to the edge of saidinternal goblet-shaped body 2. In a retracted position of the internalgoblet-shaped body 2, the circular blade 3 is located inside theexternal goblet-shaped body 1 without protruding from the edge 4 of thelatter. At the opposite side with respect to the circular blade 3 theinternal goblet-shaped body 2 has a second hollow stem 2 a which isprovided with a central hole 5 wherein a rod 6 is slidingly inserted. Incorrespondence to the part which is opposite to the one where thecentral hole 5, wherein the anvil rod 6 slides, is located, the anvilrod 6 has an end 7 to which an anvil 8 is fixed. The hollow stem 1 a ofthe external goblet-shaped body 1 of the head of the stapler shown inthe drawings is connected in a known way to a handle (not shown). Saidanvil 8 and said circular blade 3 are intended to be progressively movedcloser one to the other in order to cut the mucosa as the stapler headreach a closed position, that is when the anvil rod 6 is progressivelyretracted into the central hole 5 of the second hollow stem 2 a by meansof suitable rod retraction means (not shown in the drawings) which areincluded in the stapler handle, as it is known to a person skilled inthe art. The circular blade 3 is moved forward by suitable blade movingmeans (not shown in the drawings) which are also included in the staplerhandle, as it is known to a person skilled in the art. The edge 4 of theinternal goblet-shaped body 2 can be provided with suitable recesses 4 awhich are designed to contain suitable suture means, such as for examplemetallic staples. In FIG. 2 the stapler head is shown in the openposition and introduced in a hollow organ 9 through a hollow cylindricalintroducer 10 being provided with flanges 10 a and 10 b.

The rod 6 has, according to the invention, one or more annular grooves11 which are spaced one from the other and formed on the lateral surfaceof the rod 6 perpendicularly to the axis thereof. Said annular grooves11 are intended to receive in their inside a portion of mucosa 9 a ofthe hollow organ 9 which is included in a purse string suture (notshown) when the mucosa 9 a is tied around the rod 6. The number ofannular grooves 11 and the distance between them are suitably calibratedin order to provide a plurality of fixing positions for the purse-stringsuture on the rod so as to be always able remove an amount of mucosawhich is as large as possible.

The depth of the annular grooves 11 of the rod 6 is comprised between0.5 mm and 3 mm, preferably it is about 1 mm. The cross-section of therod 6 is preferably circular, but it can also be polygonal.

Each annular groove 11 of the rod 6 consists of a cylindrical surface12, which has a smaller diameter than the rest of the lateral surface ofthe rod 6 and is connected thereto by a fillet surface 13. The radius ofthe fillet surface 13 between the cylindrical surface 12 and the rest ofthe lateral surface of the rod 6 is preferably about 1 mm.

In order to carry out the mucosectomy with the stapler according to thepresent invention, first a purse string suture is made in a prolapsingportion of mucosa 9 a to be removed from a hollow organ 9. The staplerhead is then introduced in the hollow organ 9 in the open position, thatis with the anvil 8 being spaced from the edge 4 of the externalgoblet-shaped body 1, by making the anvil 8 pass through the pursestring suture. Subsequently the purse string suture is tied around therod 6 between the edge 4 of the external goblet-shaped body 1 and theanvil 8. In particular the purse string suture is tied around the rod 6in correspondence to an annular groove 11 which is formed on the rod 6in such a way that the portion of mucosa 9 a being included by the pursestring suture is laid therein without any possibility to slide along therod 6. In order to remove in a controlled, homogeneous and exact waylarge amounts of mucosa, a determined annular groove 11 is selectedamong the annular grooves 11 formed on the rod 6 at a well calibratedreciprocal distance.

As it is shown in FIG. 3, the stapler head is finally closed byretracting the rod 6 in the central hole 5 of the stem 2 a of theinternal goblet-shaped body 2, thus carrying the mucosa to be removedinto the internal goblet-shaped body 2 and contemporaneously causing theanvil 8 to push the mucosa to be removed against the edge 4 of theexternal goblet-shaped body 1.

After closing the stapler head by suitable rod retraction means, suturemeans 14 are applied to the mucosa of the hollow body 9 incorrespondence to the edge 4 of the external goblet-shaped body 1. Forexample, such suture means 14 can be metallic staples. Subsequently, theinternal goblet-shaped body 2 and the circular blade 3 being integralthereto are moved towards the anvil 8, by suitable moving means, thusseparating the mucosa contained in the internal goblet-shaped body 2from the mucosa of the hollow organ 9 to which the suture means 14 havebeen applied. Finally, the stapler head is extracted from the holloworgan 9.

FIGS. 4, 5 and 6 show a second alternative embodiment wherein thestapler head is suitable to apply a fragmentable compression device. Inthis embodiment the anvil 8′ is a support for a component 14′ of thecompression device to be coupled to complementary components 14″, 14″′,which are arranged in correspondence to the edge 4 of the externalgoblet-shaped body 1, when the stapler head is closed, as it is known toa person skilled in the art.

Preferably, during the mucosectomy the hollow body 9 is held open bymeans of a hollow cylindrical introducer 10, as it is shown in the FIGS.2, 3, 5 and 6.

In order to illustrate the usefulness of the presence on the rod 6 ofseveral annular grooves 11 and to highlight the biunivocalcorrespondence which is thus created between the distance of eachindividual groove 11 from the anvil 8, 8′ and the volume of mucosa to beremoved, reference is made to the following non-limiting example of astapler according to the present invention.

In a stapler provided with a circular blade 3 having a diameter of 24 mmand with a rod 6 having a diameter equal to 5 mm, 1 mm-deep annulargrooves 11 are formed on the rod 6 thus, in correspondence to thegrooves 11, the rod 6 has a diameter of 3 mm.

If an annular groove 11 was located in correspondence to the connectingpoint of the rod 6 to the anvil 8, 8′, when a purse string suture istied around the rod 6 in correspondence to said groove 11, 21 mm ofmucosa might be removed, that is two times the distance between thecircular blade 3 and the annular groove 11, said distance being equal tothe radius of 12 mm of the circular blade 3 minus the 1.5 mm radius ofthe rod 6 in correspondence to the groove 11.

In order to remove larger amounts of mucosa, it is preferable that thestapler is provided with three annular grooves 11 arranged at 10 mm, 20mm and 30 mm respectively from the anvil 8, 8′. Such grooves correspondto about 29 mm, 45 mm and 63.5 mm of mucosa which can be removed. Infact, grooves 11 which are spaced from the anvil 8, 8′, when the rod 6is retracted in the stem 2 a of the goblet-shaped body 2, allow to draginto said goblet-shaped body 2 a larger amount of mucosa, as thedistance between the circular blade 3 and the annular groove 11 whereinthe mucosa 9 a is fixed by means of the purse string suture increases,as it is shown in FIGS. 3 and 6. It is evident that the surgeon usingthe stapler according to the present invention can operate more rapidly,exactly and safely due to the present invention.

The invention claimed is:
 1. A method of performing a surgicalprocedure, comprising: securing a flexible member to a section of targettissue; securing the flexible member to a groove formed in a portion ofan anvil member; drawing the portion of the anvil member to which theflexible member is secured into a head assembly of a surgical fastenerapplying apparatus to draw a portion of the target tissue into the headassembly; and firing the surgical fastener applying apparatus to ejectone or more surgical fasteners from a body of the surgical fastenerapplying apparatus through the target tissue into the anvil member tosecure the one or more surgical fasteners to the target tissue.
 2. Themethod of claim 1, wherein securing the flexible member includessecuring the flexible member to a rod of the anvil member, the groovebeing formed in the rod.
 3. The method of claim 2, wherein securing theflexible member includes securing the flexible member directly to therod.
 4. The method of claim 1, further comprising inserting the anvilmember into an opening in a patient.
 5. The method of claim 2, whereinsecuring the flexible member to the groove includes selecting the groovefrom a plurality of grooves formed in the anvil member.
 6. The method ofclaim 5, wherein selecting the groove includes selecting one of threegrooves formed in the anvil member.
 7. The method of claim 6, whereinsecuring the flexible member to the groove includes securing theflexible member to the selected groove.
 8. The method of claim 6,wherein securing the flexible member to the groove includes securing theflexible member to the anvil member such that the flexible member issecured to the rod 10 mm from an anvil supported on a distal end of therod.
 9. The method of claim 6, wherein securing the flexible memberincludes securing the flexible member to the anvil member such that theflexible member is secured to the rod 20 mm from an anvil supported on adistal end of the rod.
 10. The method of claim 6, wherein securing theflexible member includes securing the flexible member to the anvilmember such that the flexible member is secured to the rod 30 mm from ananvil supported on a distal end of the rod.
 11. The method of claim 1,wherein drawing the portion of the anvil member to which the flexiblemember is secured into the head assembly includes approximating theanvil member and the head assembly to compress the target tissuetherebweteen.
 12. The method of claim 11, wherein firing the surgicalfastener applying apparatus includes advancing a blade member distallyto sever the target tissue.